SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)
NCT07021794 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-08-05
Summary
This placebo-controlled, randomized, blinded, two-arm phase II study will test the safety and potential efficacy of the targeted mAb, Sipavibart (formerly AZD3152) in patients with Long COVID.
Conditions
- Post-COVID / Long-COVID
Interventions
- DRUG
-
A single dose of placebo (saline) indistinguishable from the active drug in appearance
- BIOLOGICAL
-
Sipavibart
A single intramuscular dose of Sipavibart, 300 mg
Sponsors & Collaborators
-
Florida Department of Health
collaborator OTHER_GOV -
Nancy Klimas
lead OTHER
Principal Investigators
-
Nancy Klimas, MD · Nova Southeastern University
-
Amanpreet Cheema, PhD · Nova Southeastern University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-16
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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